MAUDE Adverse Event Report: RESPIRONICS, INC. M AF811 MASK; FULL FACE MASK

Model Number	1063052
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device information in complaint details: 1063052 c-pap nasal mask (medium) ¿ ref (b)(4) and lot: 191114 same patient, additional device (mask) captured in complaint ra (b)(4) h3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer was contacted in reference to a af811 oro-nasal mask.The patient alleges while in use, the safety valve closes on a spontaneous breath on the nasal mask.At the time this issue occurred, use of the device was stopped and restarted.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported information n reference to a af811 oro-nasal mask.The patient alleges while in use, the safety valve closes on a spontaneous breath on the nasal mask.At the time this issue occurred, use of the device was stopped and restarted.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Updated: section b: adverse event/product problem: changed to "product problem".Section h: type of reported complaint: changed to "product problem".Section h: health impact grid: changed to "no health consequences or impact".

• Brand Name: M AF811 MASK
• Common Device Name: FULL FACE MASK
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18472273
• Report Number: 2518422-2024-01291
• Device Sequence Number: 17863802
• Product Code: BZD
• UDI-Device Identifier: 30606959034359
• UDI-Public: 30606959034359
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K073600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1063052
• Device Catalogue Number: 1063052
• Device Lot Number: 191114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2023
• Supplement Date Received by Manufacturer: 12/09/2023
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown